AMO Sensar Intraocular Lenses — Class II medical device recall Z-0929-2013
Terminated recall by Abbott Medical Optics Inc (AMO), reported 2013-03-20, distributed nationwide. Two production orders of these IOLs that contain mislabeled IOLs.
| Recall number | Z-0929-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical Optics Inc (AMO), Santa Ana, CA, United States |
| Recall initiated | 2012-12-20 |
| Classified | 2013-03-09 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CH, CN, DE, FR, GB, HR, HU, IT, SE, SG, TR |
| Quantity | 155 units |
| Reason classes | labeling |
| Model numbers | AR40E |
Product
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Reason for recall
Two production orders of these IOLs that contain mislabeled IOLs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0929-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.